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Zimmer Biomet Announces Quarterly Dividend for Fourth Quarter of 2019

On December 16, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the fourth quarter of 2019 (Press release, Zimmer Holdings, DEC 16, 2019, View Source [SID1234552413]).

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The cash dividend of $0.24 per share is payable on January 31, 2020 to stockholders of record as of the close of business on December 27, 2019.

VolitionRx Limited Announces Strategic Acquisition

On December 16, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported an agreement by its subsidiary Belgian Volition SPRL to acquire an epigenetic reagent company, Octamer GmbH ("Octamer"), for approximately $725,000 consisting of cash and shares of restricted common stock of Volition (Press release, VolitionRX, DEC 16, 2019, View Source [SID1234552412]). The closing of the acquisition is subject to customary conditions and is expected to occur in January 2020. This strategic acquisition helps secure the supply of one of the key components of Volition’s Nu.QTM tests, the recombinant nucleosome used as the calibrant.

Commenting on the announcement Cameron Reynolds, Chief Executive Officer of Volition said, "I could not be happier that through this acquisition we will be working with one of the world’s leading nucleosome experts, Dr. Adrian Schomburg. Not only will this deal secure the supply of a wide range of our key components, but it will also facilitate the transfer of know-how and expertise so that we can develop the capability to manufacture recombinant nucleosomes ourselves. This deal enhances our goal of becoming one of the world’s leading epigenetics companies."

Regarding the transaction, Dr. Adrian Schomburg, Founder and CEO of Octamer said, "I believe that the progress that Volition has made to date on nucleosomes in circulation is very exciting and have confidence that this deal is a good convergence of our two technologies and companies. I look forward to working together to bring these transformative diagnostic agents into everyday diagnostic practice."

In addition to nucleosomes, Octamer manufactures and sells histones, octamers and DNA templates. These reagents can be used for custom applications in epigenetic research and drug discovery. Octamer is already revenue generating and has many business development opportunities that Volition plans to exploit in 2020 and beyond.

About the Acquisition

The aggregate purchase price is €650,000 Euros (approximately $725,000), consisting of €350,000 cash and approximately 73,000 shares of common stock of Volition, for 100% of the outstanding shares of Octamer. The shares of common stock will be issued by Volition to the seller in a private placement in reliance on an exemption from the registration requirements of the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder. The shares of common stock will not be registered under the Securities Act or any state securities laws and unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. In connection with the transaction, the parties will also enter into a five-year royalty agreement the provides for single-digit royalties based on the sales by Octamer of recombinant nucleosomes to pharmaceutical companies for use in the development, manufacture and screening of molecules for use as therapeutic drugs, as well as a consulting arrangement with Dr. Schomburg. The acquisition includes the transfer of Standard Operating Procedures and key assets in addition to onsite training for Belgian Volition scientists.

ORIC Pharmaceuticals Presents Preclinical Data on Glucocorticoid Receptor Antagonist at 2019 San Antonio Breast Cancer Symposium

On December 16, 2019 ORIC Pharmaceuticals, a privately held, clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that new preclinical data on its lead program, ORIC-101, a selective and potent glucocorticoid receptor (GR) antagonist currently being investigated in a Phase 1b clinical trial in combination with nab-paclitaxel in patients with advanced solid tumors, at the 2019 San Antonio Breast Cancer Symposium (Press release, ORIC Pharmaceuticals, DEC 16, 2019, https://www.prnewswire.com/news-releases/oric-pharmaceuticals-presents-preclinical-data-on-glucocorticoid-receptor-antagonist-at-2019-san-antonio-breast-cancer-symposium-300974917.html [SID1234552411]).

The ORIC-101 preclinical data were presented in a poster titled, "ORIC-101 Robustly Inhibits the Glucocorticoid Pathway and Overcomes Chemoresistance in TNBC" (Program Number: P6-03-24, Abstract #2507).

GR is highly expressed in a variety of cancers including prostate, pancreatic, ovarian, triple-negative breast cancer (TNBC) and endometrial cancers. Preclinical studies have indicated that activation of GR reduces the efficacy of chemotherapy, while inhibition of GR with the antagonist ORIC-101 enhances the efficacy of chemotherapy in multiple solid tumor models.

ORIC-101 potently sensitizes TNBC cells to chemotherapy by reversing GR-mediated resistance through the epithelial-to-mesenchymal transition and anti-apoptosis pathways, in both in vitro and in vivo preclinical models. The poster presented a GR activation signature developed at ORIC that includes the direct GR transcriptional targets FKBP5 and GILZ and subsequently validated both genes as ORIC-101 pharmacodynamic (PD) biomarkers. The relationship between PD biomarkers, pharmacokinetics and efficacy in preclinical models was also assessed. The data demonstrated that ORIC-101 robustly inhibits the transcriptional induction of PD biomarkers and fully reverses GR-mediated chemoresistance in vitro and in vivo.

In addition to its ongoing Phase 1b clinical trial of ORIC-101 in combination with nab-paclitaxel, ORIC is also conducting a second Phase 1b clinical trial of ORIC-101 in combination with enzalutamide in patients with metastatic prostate cancer.

Futility Analysis Performed of the Phase II Combination Study with Birinapant and Keytruda® in Colorectal Cancer Patients

On December 16, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the independent safety committee (IDMC) for the phase II study of birinapant in combination with pembrolizumab (Keytruda) in patients with MSS colorectal cancer has performed the planned futility analysis (Press release, Medivir, DEC 16, 2019, View Source [SID1234552410]). The primary objective of the phase II study was an improved clinical response to treatment measured as 20% ORR (Overall Response Rate). IDMC’s recommendation is that the study should be terminated as the analysis indicates that it is unlikely that the study’s objectives will be met. Medivir has therefore decided to discontinue the recruitment of patients and to end the study.

"We are disappointed that the combination therapy with birinapant and pembrolizumab did not work better in this difficult-to-treat patient group where monotherapy with pembrolizumab has very limited effect", said Dr Uli Hacksell, CEO of Medivir. "But we still see a potential for other combination therapies where birinapant could offer patients improved treatment. One example is the ongoing phase I study of a combination of birinapant and radiation therapy in patients with head and neck cancer."

A total of 15 patients with advanced MSS colorectal cancer were recruited in the phase II study, 14 of which were included in the futility analysis. The combination therapy was considered acceptable from a safety perspective, but none of the patients showed a clear clinical efficacy response. Four patients were judged to have stable disease while 10 were judged to have disease progression.

The phase II study was conducted as a collaboration between Medivir and MSD, who provided pembrolizumab.

For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46-(0)-8-5468-3100.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16.00 CET on 16 December, 2019.

About Birinapant

Birinapant is being developed to enhance responses, and extend survival, of patients with solid tumors where existing treatments do not provide sufficient survival benefit, or where patients no longer have treatment options. Based on its unique design and mechanism, birinapant has the potential to enhance patients’ responses in combination with other treatments.

Platelet BioGenesis Receives $2.3 Million Award from the Medical Technology Enterprise Consortium to Accelerate Development of Donor-Independent Platelet Production

On December 16, 2019 Platelet BioGenesis, Inc. (PBG), the leader in stem cell-derived, on-demand human platelets (PLTs+) and genetically engineered platelet-based therapeutics, reported it received an award of $2.3 million from the Medical Technology Enterprise Consortium (MTEC) – a 501(c)(3) biomedical technology consortium collaborating with the U.S. Army Medical Research and Development Command (USAMRDC) (Press release, Platelet BioGenesis, DEC 16, 2019, View Source [SID1234552409]). PBG will use the funding to accelerate the development of an automated, mobile bioreactor that produces PLT+ packs for use at field hospitals and other military medical posts.

MTEC partners with private industry, academic institutions, government agencies and other research organizations seeking to accelerate the development of medical solutions that prevent and treat injuries to U.S. military members. One of the organization’s current objectives is to identify devices or therapies that empower medics to do more treatment at the point of injury. MTEC’s work with PBG will enable the development of a mobile bioreactor that can produce PLTs+ on-demand in the regions where military operations are underway, alleviating platelet shortages in conflict zones caused by lack of donor availability, short platelet shelf life and sterility concerns.

"Military conflict zones are often in remote locations, meaning that medical technology innovations are paramount to effective interventions and recoveries," said Kathy Zolman, MTEC Director of Program Operations. "The work Platelet BioGenesis is doing could help resolve the shortages that often affect U.S. military units. Developing the bioreactor for remote applications would enable platelets to be available on-demand, which would make an immense difference in treating traumatic injuries sustained during military activity."

In another important development, PBG has added Uma Lakshmipathy, Ph.D. and Teresa Foy, Ph.D. to its Scientific Advisory Board (SAB) to support the continued research and development of platelet-based therapeutic solutions. Dr. Lakshmipathy is the R&D Director at Thermo Fisher Scientific and is involved in the development of reprogramming, engineering and characterization solutions that support translation of primary and stem cells towards novel cell therapy platforms. Dr. Foy is Senior Vice President at Bristol-Myers Squibb (BMS, formerly Celgene), leading the Thematic Research Center for Immuno-Oncology (IO) and Cellular Therapy (CT). She is responsible for BMS’s IO/CT discovery and early development pipeline, leading a team that is advancing novel drug and cell therapy candidates from discovery through clinical proof-of-concept.

"Dr. Lakshmipathy and Dr. Foy bring to PBG extensive experience in the development of cell therapies, which will be invaluable as we enter IND-enabling studies of our human stem cell-derived, donor-independent platelets in 2020. We look forward to working closely with both of these distinguished industry veterans as we continue to advance our novel platelet-based cell therapy platform," said Sam Rasty, Ph.D., the company’s President and CEO. "In addition to bolstering our SAB with these highly experienced advisors, the MTEC award provides us with further non-dilutive funding and validation of our science and technology platform. We look forward to partnering with MTEC to advance the development of our mobile, automated PLT+ bioreactor."